MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-31 for LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT LSM1350726 manufactured by Clearstream Technologies Ltd..
[177269093]
Manufacturing review: the lot number was provided, and the lot device history records have been reviewed. The lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only complaint that has been reported for this corporate lot number to date. Investigation summary: the investigation is unconfirmed for the reported device incompatibility issue. While an attempt was made to insert the device through the returned cook 6f 55cm sheath failed, it successfully passed through an in house 6fr terumo radifocus 10cm sheath without issue during the evaluation. It is unknown patient factors, procedural or handling techniques contributed to the reported event. The definitive root cause for the reported device incompatibility issue could not be determined based upon information received from the field communications or the returned sample. Labeling review: the ifu for the lifestream product was reviewed and contains the following information relevant to the reported event: precautions: the device should only be used by physicians who are trained in endovascular procedures and are familiar with the complications, side effects and hazards of peripheral vascular interventions. Prior to device use, refer to the covered stent sizing table on the label and read the instructions for use. Crossing the implant with catheters or other adjunct devices can result in covered stent dislodgement or damage. Potential patient/device adverse effects that may occur include, but are not limited to, the following: covered stent dislodgement from balloon during tracking procedure. Covered stent misplacement during placement procedure. Directions for use: site access and preparation: using standard techniques access the artery and place an introducer sheath or guiding catheter of appropriate inner diameter and a 0. 035" (0. 89 mm) guidewire across the target lesion. Covered stent size selection: select a covered stent diameter that is approximately 5%-20% larger than the largest reference vessel diameter at the proximal or distal target site. Refer to the sizing table on the packaging label for appropriate selection of the covered stent diameter and length. Endovascular system preparation: carefully remove the selected device from the package. Inspect the covered stent for adherence to the balloon and centered placement in relation to the balloon marker bands. If the covered stent is not centered and/or does not firmly adhere to the balloon, do not use. Flush the delivery system guidewire lumen with sterile saline mixture until saline drops from the distal end of the endovascular system. Air evacuation: a 20 cc or smaller luer-lock syringe with a minimum of 5 cc? S sterile saline mixture is recommended for use for aspirating this device. With the distal balloon tip pointing down and positioned below the level of the syringe, pull negative pressure until all air is expelled. Induce a negative pressure to remove any air from the balloon and inflation lumen. Repeat until all air is expelled. Carefully release to neutral. Allow the inflation lumen to fill with the diluted contrast medium and maintain a neutral pressure. Important: do not apply positive pressure to the balloon. Attach the prefilled inflation device to the inflation lumen of the catheter hub, ensuring no air bubbles remain at the catheter connection. Verify that the covered stent is still centered between the two radiopaque markers on the balloon catheter. Introduction of the endovascular system and placement of the covered stent. Advance the endovascular system over the guidewire into the introducer sheath. The catalog number identified, has not been cleared in the u. S. But, it is similar to the lifestream balloon expandable vascular covered stent products that are cleared in the us. The 510 k number and pro code for the lifestream balloon expandable vascular covered stent products are identified.
Patient Sequence No: 1, Text Type: N, H10
[177269094]
It was reported that during a cross-over procedure for the external iliac, the delivery system allegedly became stuck in the proximal end of the introducer sheath after two advancement attempts. It was further reported that the delivery system and introducer sheath were removed as one unit without consequence. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616666-2020-00013 |
| MDR Report Key | 9654429 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-31 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2020-01-06 |
| Device Manufacturer Date | 2017-10-18 |
| Date Added to Maude | 2020-01-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | CLEARSTREAM TECHNOLOGIES LTD. |
| Manufacturer Street | MOYNE UPPER |
| Manufacturer City | ENNISCORTHY, CO. WEXFORD N A |
| Manufacturer Country | EI |
| Manufacturer Postal Code | N A |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT |
| Generic Name | BALLOON EXPANDABLE VASCULAR COVERED STENT |
| Product Code | PRL |
| Date Received | 2020-01-31 |
| Returned To Mfg | 2020-01-13 |
| Catalog Number | LSM1350726 |
| Lot Number | CMBX0272 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLEARSTREAM TECHNOLOGIES LTD. |
| Manufacturer Address | MOYNE UPPER ENNISCORTHY, CO. WEXFORD N A EI N A |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-31 |